Clinical Utility of Biocept's Liquid Biopsy Platform Demonstrated in Study Results Presented at the 2016 San Antonio Breast Cancer Symposium

SAN DIEGO, Dec. 8, 2016 /PRNewswire/ -- Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of clinically actionable liquid biopsy tests to improve the management of cancer patients, announces that clinical data featuring its Target Selector™ Circulating Tumor Cell platform demonstrated high concordance to tissue biopsy for the detection of actionable biomarkers in patients with metastatic breast cancer. The results from research sponsored by Sara Cannon Research Institute (SCRI), the research arm of Sarah Cannon, the global cancer enterprise of Hospital Corporation of America, were presented in a poster at the 2016 San Antonio Breast Cancer Symposium held in San Antonio, Texas.

The poster entitled, "Using the Target Selector™ platform to evaluate biomarker alterations in circulating tumor cells isolated from patients with metastatic breast cancer," was presented by Denise A. Yardley, M.D., Senior Investigator of the Breast Cancer Research Program at SCRI, and Medical Oncologist at Tennessee Oncology. The study evaluated 74 late-stage breast cancer patients whose metastatic tumors had been molecularly characterized using tissue biopsies, and the data showed that circulating tumor cells (CTCs) were detected in nearly all patients (73/74). Biocept's proprietary platform differentiated between patients whose CTCs had cytokeratin positive (CK+) expression (62%) and those with only cytokeratin negative CTCs (38%). Despite significant latency in most cases between the time of tissue biopsy and the time of testing with Biocept's liquid biopsy assay, results showed high concordance of key biomarkers in patients with CK+ expression. Results for individual biomarkers found in these patients were:

• 84% concordance for ER expression
• 93% concordance for HER2 amplification
• 79% concordance for FGFR1 amplification

The capability of Biocept's Target Selector™ platform to distinguish between CK+ and CK- cells enables the ability to track these CTC subtypes contemporaneously as a potential prognostic indicator.

"The identification of circulating tumor cells in nearly all patients in this study and the high concordance between Biocept's blood-based assay and archival tissue samples for detecting actionable biomarkers in patients with CK+ CTCs are encouraging," said Dr. Yardley.  "This methodology has potential to be used as an alternative to tissue biopsy when tumor biopsy material is insufficient or not readily available under certain circumstances, such as metastases to the bone. Additionally, the liquid biopsy tests afford the ability to assess and monitor key biomarkers in advanced breast cancer patients and potentially detect changes in tumor phenotype that can occur over time."

"These study results demonstrate that our non-invasive assay platform can address important medical needs in the management of metastatic breast cancer, namely the ability to establish biomarker status when tissue biopsy is challenging or not possible, as well as providing the ability to detect actionable alterations in real-time as metastatic disease progresses," said Veena Singh, M.D., Biocept's Senior Vice President and Senior Medical Director. "We are very pleased with the concordance results observed in this study, as well as our ability to detect CTCs in most patients to help physicians select the best treatment approach".

"We are proud to present these data from our clinical collaboration with SCRI, which we announced in mid-2015," added Michael W. Nall, President & Chief Executive Officer of Biocept. "This is yet another step in validating the clinical utility of our Target Selector™ platform, which uses a simple blood sample to inform physicians about the molecular status of a patients' cancer, potentially leading to improved treatment outcomes. Building clinical evidence to support the use of our proprietary liquid biopsy platform is an important component of our strategy to increase physician adoption of our assays."

About the San Antonio Breast Cancer Symposium

The 2016 San Antonio Breast Cancer Symposium is designed to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis and therapy of breast cancer and premalignant breast disease to an international audience of physicians and researchers. The symposium is directed primarily toward academic and private physicians and researchers involved in breast cancer in medical, surgical, gynecologic and radiation oncology, as well as other appropriate health care professionals. Approximately 7,500 attendees from more than 90 countries are expected to have attended the 2016 symposium.

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is a global strategic research organization focusing on advancing therapies for patients. It is one of the world's leading clinical research programs, conducting community-based clinical trials in oncology and cardiology through affiliations with a network of more than 1,000 physicians in the United States and United Kingdom. Additionally, SCRI offers management, regulatory, and other research support services for drug development and industry sponsors and strategic investigator sites.

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient's disease and therapeutic options. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the management of cancer patients and improve treatment outcomes, the ability of our platform to serve as a prognostic indicator and detect changes in tumor phenotypes, and our ability to increase physician adoption of our assays, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

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SOURCE Biocept, Inc.

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